Quality Systems, Contractor jobs in United States
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Planet Pharma · 14 hours ago

Quality Systems, Contractor

Planet Pharma is a company focused on maintaining compliance and supporting the integrity of Quality Systems. The Coordinator 2, Quality Systems is responsible for managing GxP records, supporting quality event processes, and ensuring compliance with regulatory standards.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Administer and monitor quality event processes, ensuring conformance to standards, and track operational performance
Sort and categorize records in alignment with retention schedules, regulatory requirements, and company procedures
Organize and maintain physical and electronic records to ensure accessibility, accuracy, and traceability
Support complaint handling processes by accurately entering product complaint data into the system
Assist with the maintenance and issuance of controlled logbooks
Provide support across Quality System areas, including audits, CAPAs, document control, and training activities
Perform additional duties as assigned to meet departmental and organizational objectives

Qualification

Records managementRegulatory complianceQuality Management SystemsCustomer complaint processesGxPInterpersonal skillsWork ethic

Required

High School Diploma (or equivalent) with 4+ years of experience in life sciences or medical device industry
Strong foundation in records management and regulatory compliance
Familiarity with MasterControl or similar Quality Management Systems
Broad Experience In Quality Functions, Including Customer Complaint Processes
Knowledge of GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and related regulations and standards
Demonstrates integrity, self-confidence, and commitment to prioritizing customer and patient safety
Excellent interpersonal skills; able to collaborate effectively across all organizational levels
Strong work ethic with a proactive approach—eager to learn, take on new responsibilities, and seek additional tasks when available

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.

H1B Sponsorship

Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase